Caiman Seal and Cut Technology
FDA 510(k) clearance K151858 · decided 2015-07-21
Clearance details
- K-number
- K151858
- Device name
- Caiman Seal and Cut Technology
- Applicant
- Aesculap, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-07-08
- Decision date
- 2015-07-21
- Days to decision
- 13 days
- Clearance type
- Special
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Center Valley, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories recall (Z-1218-2017) | Aesculap Implant Systems LLC | 2017-02-16 |